IncobotulinumtoxinA (Xeomin) Versus Placebo in the Treatment of Glabellar Frown Lines

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Merz Pharmaceuticals GmbH

ClinicalTrials.gov Identifier:

NCT00430963

First received: February 1, 2007

Last updated: October 25, 2011

Last verified: October 2011

History of Changes

Tracking Information

First Received Date ^ICMJE

February 1, 2007

Last Updated Date

October 25, 2011

Start Date ^ICMJE

October 2006

Primary Completion Date

April 2007 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Investigator's assessment according to the Facial Wrinkle Scale (FWS) [ Time Frame: Day 30 ] [ Designated as safety issue: No ]
Responder: FWS score of 0 or 1.
Patient's global assessment [ Time Frame: Day 30 ] [ Designated as safety issue: No ]
Responder: subjects with a score of at least 2+.

Original Primary Outcome Measures ^ICMJE

Investigator's assessment
Patient's assessment

Change History

Complete list of historical versions of study NCT00430963 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Investigator's assessment according to FWS [ Time Frame: Day 7, 60, 90, and 120 ] [ Designated as safety issue: No ]
Responder: FWS score of 0 or 1.
Patient's global assessment [ Time Frame: Day 7, 60, 90, and 120 ] [ Designated as safety issue: No ]
Responder: subjects with a score of at least 2+.

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

IncobotulinumtoxinA (Xeomin) Versus Placebo in the Treatment of Glabellar Frown Lines

Official Title ^ICMJE

A Prospective, Randomized, Double-blind, Placebo-controlled, Multicenter Trial With an Open-label Extension Period to Investigate the Efficacy and Safety of IncobotulinumtoxinA (Xeomin), Free of Complexing Proteins, in the Treatment of Glabellar Frown Lines

Brief Summary

IncobotulinumtoxinA (Xeomin) is a botulinum toxin type A preparation free of complexing proteins, i.e. free of proteins other than the active toxin. Injected into the muscle, IncobotulinumtoxinA (Xeomin) causes local weakening. Botulinum toxin type A is widely used for aesthetic treatment of facial lines. This study investigated the efficacy and safety of IncobotulinumtoxinA (Xeomin) in the treatment of glabellar frown lines compared to placebo. The study consisted of a Main Period and an Open-Label Extension [OLEX] Period of 120 days each.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment

Condition ^ICMJE

Glabellar Frown Lines

Intervention ^ICMJE

Drug: IncobotulinumtoxinA (Xeomin) (20 Units)
Drug: Placebo
Other Name: Placebo

Study Arm (s)

Placebo Comparator: Placebo
Placebo to IncobotulinumtoxinA (Xeomin) powder for solution for injection; dose: one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl, corresponding to total placebo volume 0.5 mL; mode of administration: intramuscular injection

Intervention: Drug: Placebo
Experimental: IncobotulinumtoxinA (Xeomin) (20 Units)
IncobotulinumtoxinA (Xeomin), also known as 'NT 201' or 'Botulinum toxin type A (150 kD), free from complexing proteins' (active ingredient: Clostridium Botulinum neurotoxin type A free from complexing proteins) powder for solution for injection; dose: one injection session of solution, prepared by reconstitution of powder with 0.9% sodium chloride (NaCl), 20 units, total volume 0.5 mL, mode of administration: intramuscular injection

Intervention: Drug: IncobotulinumtoxinA (Xeomin) (20 Units)

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

256

Completion Date

November 2007

Primary Completion Date

April 2007 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

•Moderate to severe glabellar frown lines

Exclusion Criteria:

Previous insertion of permanent material in the glabellar area
Neuromuscular function disease

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Germany

Administrative Information

NCT Number ^ICMJE

NCT00430963

Other Study ID Numbers ^ICMJE

MRZ 60201-0520/1

Has Data Monitoring Committee

Responsible Party

Merz Pharmaceuticals GmbH

Study Sponsor ^ICMJE

Merz Pharmaceuticals GmbH

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Medical Expert

Merz Pharmaceuticals GmbH

Information Provided By

Merz Pharmaceuticals GmbH

Verification Date

October 2011

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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